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Statement from the Cystic Fibrosis Foundation on Passage of the EXPERRT Act in House of Representatives
Date:6/20/2012

BETHESDA, Md., June 20, 2012 /PRNewswire-USNewswire/ -- The Cystic Fibrosis Foundation issued the following statement in response to passage of legislation today in the House of Representatives to expand consultation between the Food and Drug Administration (FDA) and external rare disease experts and patient advocates during the FDA drug approval process. 

The bill is known as the Expanding and Promoting Expertise in Review of Rare Treatments Act (EXPERRT). It was introduced by Reps. Edward Markey (D-MA), Tom Marino (R-PA) and Cliff Stearns (R-FL).  EXPERRT passed as part of the Food and Drug Administration Safety and Innovation Act, which reauthorizes the FDA's user-fee program that funds its drug and device evaluation.

"The Cystic Fibrosis Foundation applauds the approval of the EXPERRT Act, which will help expedite the approval of safe and effective new rare-disease drugs and treatments for patients by ensuring that the FDA has the most complete information during its evaluation," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. "This legislation is critically important to the 30,000 Americans with cystic fibrosis and millions more with rare diseases who desperately need access to sophisticated therapies for their complex conditions. We extend our special thanks to Representatives Markey, Marino and Stearns for the critical work they have done to advance this legislation."

"The inclusion of the EXPERRT Act in the FDA Safety and Innovation Act ensures that sharing knowledge amongst the FDA and individuals with expertise in rare diseases will become common practice," said Markey, co-chair of the Congressional Cystic Fibrosis Caucus. "Information about the severity of diseases, the risks patients may be willing to take, or improved clinical trial designs will help facilitate the review process and bring new treatments for rare diseases like cystic fibrosis to market quicker and more easily."'/>"/>

SOURCE Cystic Fibrosis Foundation
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